BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650

    K Number: K022934 · Decision Nov 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    2
    Review Days
    71

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    Basic Information

    Device Name
    SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650
    K Number
    K022934
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits
    Date Received
    September 4, 2002
    Decision Date
    November 14, 2002
    Product Code
    BZD
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BZD Ventilator, Non-Continuous (Respirator)

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